1. Addition of bevacizumab to chemotherapy in acute myeloid leukemia at older age: a randomized phase 2 trial of the Dutch-Belgian Cooperative Trial Group for Hemato-Oncology (HOVON) and the Swiss Group for Clinical Cancer Research (SAKK).
- Author
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Ossenkoppele GJ, Stussi G, Maertens J, van Montfort K, Biemond BJ, Breems D, Ferrant A, Graux C, de Greef GE, Halkes CJ, Hoogendoorn M, Hollestein RM, Jongen-Lavrencic M, Levin MD, van de Loosdrecht AA, van Marwijk Kooij M, van Norden Y, Pabst T, Schouten HC, Vellenga E, Verhoef GE, de Weerdt O, Wijermans P, Passweg JR, and Löwenberg B
- Subjects
- Acute Disease, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized administration & dosage, Antibodies, Monoclonal, Humanized adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Belgium, Bevacizumab, Biomedical Research, Disease-Free Survival, Drug Administration Schedule, Female, Hematologic Neoplasms diagnosis, Hematologic Neoplasms therapy, Humans, International Cooperation, Length of Stay, Male, Middle Aged, Netherlands, Remission Induction, Switzerland, Time Factors, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Leukemia, Myeloid drug therapy
- Abstract
An urgent need for new treatment modalities is emerging in elderly patients with acute myeloid leukemia (AML). We hypothesized that targeting VEGF might furnish an effective treatment modality in this population. Elderly patients with AML were randomly assigned in this phase 2 study (n = 171) to receive standard chemotherapy (3 + 7) with or without bevacizumab at a dose of 10 mg/kg intravenously at days 1 and 15. In the second cycle, patients received cytarabine 1000 mg/m(2) twice daily on days 1-6 with or without bevacizumab. The complete remission rates in the 2 arms were not different (65%). Event-free survival at 12 months was 33% for the standard arm versus 30% for the bevacizumab arm; at 24 months, it was 22% and 16%, respectively (P = .42). The frequencies of severe adverse events (SAEs) were higher in the bevacizumab arm (n = 63) compared with the control arm (n = 28; P = .043), but the percentages of death or life-threatening SAEs were lower in the bevacizumab arm (60% vs 75% of SAEs). The results of the present study show that the addition of bevacizumab to standard chemotherapy does not improve the therapeutic outcome of older AML patients. This trial is registered as number NTR904 in The Nederlands Trial Register (www.trialregister.nl).
- Published
- 2012
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